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Portable Mesh Nebulizer

by Shenzhen Jermei Medical Device Technology Co., Ltd. 6 variants

Ref /Model JM802,JM810, JM811,JM817, JM818,JM821,JM822,JM827, JM828,JM829, JM830,JM832,JM833, JM835,JM836, JM837, JM838,JM839, JM841, JM842,JM843,JM888

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

5 May 2031

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier SGS FIMKO OY

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697243381JM821EQ Basic UDI-DI 06972433811185UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06972433811185 UDI-DI Date1 Jan 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI26/1008024 Active

    Quality management system EU MDR

    Certifier
    SGS FIMKO OY 0598
    Issued
    6 May 2026
    Expires
    5 May 2031

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Portable Mesh Nebulizer EUDAMED
Jermei GUDID
Generic Name
Therapeutic agent nebulizer, benchtop
Model / Reference
JM802, JM810, JM811, JM817, JM818, JM821, JM822, JM827, JM828, JM829, JM830, JM832, JM833, JM835, JM836, JM837, JM838, JM839, JM841, JM842, JM843, JM888, /
Primary DI / UDI-DI
06972433811185
Basic UDI-DI
697243381JM821EQ
Direct Marketing DI
06972433811185
510(k) Number
FDA Product Code
CAF
EMDN Code
Z12040210 Ultrasonic nebulisers
GMDN Term
Therapeutic agent nebulizer, benchtop
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5630
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000039164
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Shenzhen Jermei Medical Device Technology Co., Ltd

See all devices from Shenzhen Jermei Medical Device Technology Co., Ltd →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No